Diabetic Retinopathy
Conditions
Brief summary
A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.
Detailed description
A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.
Interventions
DEVICEhandheld fundus camera
Fundus camera
Sponsors
Laboratory Corporation of America
Digital Diagnostics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 22 years of age or older 2. Documented diagnosis of diabetes mellitus, as per any of the following: 1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA) 2. Hemoglobin A1c (HbA1c) ≥ 6.5% 3. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) 4. Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water 5. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L) 3. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
1. Currently participating in an interventional eye study 2. Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops 3. Has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation) 4. Pregnancy 5. Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters 6. History of laser treatment of the retina, injections into either eye, or any history of retinal surgery 7. Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion) 8. Any condition that is contraindicated for the use of the study camera 9. Contraindication for imaging by devices used in the study due to any of the following: 1. Subject is hypersensitive to light 2. Subject recently underwent photodynamic therapy (PDT) 3. Subject is taking medication that causes photosensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity Corrected for Enrichment | Day 1 | Estimation sensitivity and specificity corrected for enrichment using logistic regression, Level 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed Sensitivity and Specificity, Level II | Day 1 | Estimation diagnosability, and observed sensitivity and specificity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Precision substudy | ~1-month after Day 1 | Evaluate the repeatability and reproducibility of IDx-DR with the camera in protocol DXSDR006. Additionally, another IRB-approved R&R study (i.e., similar to DXSDR006 precision substudy) was conducted to evaluate parameters that may optimize R&R outcomes. |
Countries
United States
Outcome results
None listed